(159 days)
Not Found
No
The description focuses on the mechanical aspects of a steerable sheath and does not mention any computational or data-driven components indicative of AI/ML.
No.
The device facilitates the introduction of diagnostic/therapeutic catheters; it is not therapeutic itself.
No
The device is described as "intended to facilitate transvenous introduction of diagnostic/therapeutic catheters," indicating it is a tool for delivering other devices, not a diagnostic device itself.
No
The device description clearly outlines physical components (shaft, handle, dilator, guidewire) and describes bench testing related to physical properties and biocompatibility, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate transvenous introduction of diagnostic/therapeutic catheters into the vasculature, and into the chambers of the heart." This describes a device used in vivo (within the body) to deliver other devices.
- Device Description: The description details a physical sheath, dilator, and guidewire used for accessing the vasculature. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information. The device's function is purely mechanical and procedural.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform such a function.
N/A
Intended Use / Indications for Use
The Z°Flex-270TM Steerable Sheath is intended to facilitate transvenous introduction of diagnostic/therapeutic catheters into the vasculature, and into the chambers of the heart.
Product codes
DRA
Device Description
The Z°Flex-270™ Steerable Sheath is a 12 Fr percutaneous steerable sheath with a flexible tip designed for gaining access to the vasculature including the coronary systems. It is comprised of two (2) main sections: the shaft and the handle. The Z°Flex-270 Steerable Sheath has uni-directional adjustable tip geometry with a rotating mechanism on the handle used to control sheath deflection. A dilator and guidewire are included with each kit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature, chambers of the heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance (bench) testing and biocompatibility testing were performed to demonstrate that the proposed device performs as intended and does not raise new questions of safety or efficacy compared to the predicate device.
Testing included:
- Sterilization testing per ISO 11135-1.
- Shelf Life.
- Packaging.
- Performance (Bench) testing:
- Visual
- Dimensional
- Functional
- Hemostasis valve leak testing (per ISO 11070)
- Deflection testing.
- Air aspiration and hemostasis
- Fatigue testing (deflection)
- Sheath tip robustness testing after multiple catheter deployment/retractions
- Kink resistance.
- Torque.
- Tensile testing.
- Dilator to sheath retention.
- Guidewire testing per ISO 11070
Biocompatibility testing for the subject device included: - Cytotoxicity.
- Sensitization
- Irritation/Intracutaneous Reactivity.
- Acute Systemic Toxicity.
- Materials Mediated Rabbit Pvrogen.
- Hemolysis
- Partial Thromboplastin Time
- Platelet and Leukocyte Counts
- Complement Activation
- Thrombosis (In-vivo) 4 hour contact.
- Testing for Latex, DEHP, and Bisphenol A.
Conclusion: Test results demonstrate that the Z°Flex-270 Steerable Sheath met all specifications per functional and performance requirements. The device performs as intended and does not raise any new questions of safety or efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).
0
Trade Name: ZºFlex-270TM Steerable Sheath Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Catheter Regulatory Class: II (two) Product Code: DRA Dated: November 30, 2011 Received: December 1, 2011
Dear Ms. Bakker:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Ms. Sara Bakker
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance: Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
וכר
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
5
Indications for Use Statement
510(k) Number (if known):_K|| 254 l
Device Name: Z°Flex-2707M Steerable Sheath
Indications for Use:
The Z°Flex-270TM Steerable Sheath is intended to facilitate transvenous introduction of diagnostic/therapeutic catheters into the vasculature, and into the chambers of the heart.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K112541